IL-2 "SELECT" Tissue Collection Protocol in Patients With Advanced Melanoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Dana-Farber Cancer Institute.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Dana-Farber Cancer Institute
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01288963
First received: February 1, 2011
Last updated: April 7, 2011
Last verified: April 2011
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Purpose
The purpose of this study is to determine which participants with melanoma have a better response to IL-2 and to identify markers that may predict response to IL-2 by collecting participant information (for example; cancer diagnosis and history, prior treatments for cancer, etc.) blood and tumor samples prior to treatment and tumor measurements after treatment.
| Condition | Intervention |
|---|---|
|
Malignant Melanoma |
Other: Observation |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | The High-Dose Aldesleukin (IL-2) "SELECT" Trial: A Prospective Tissue Collection Protocol to Investigate Predictive Models of Response to High-Dose IL-2 Treatments in Patients With Advance Melanoma |
Resource links provided by NLM:
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
- To determine if DASL subclassification can identify a group of patients with advanced melanoma who are significantly more likely to respond to high dose IL-2 based on therapy than the historical 16% response rate in an unselected patient population [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To validate the usefulness of serum fibronectin and VEGF levels as negative predictors of response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To explore the predictive value of several genetic polymorphisms associated with immune function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To explore the predictive value of BRAF^V600E mutational status as a predictor of response and benefit to high dose IL-2 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To explore the relationship of serum fibronectin and VEGF levels with the molecular signature of immune responsiveness in patients with advanced melanoma receiving high-dose IL-2 in order to identify specific cohorts with dramatic differences in response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- To identify new proteins or patterns of gene expression that might be associated with high-dose IL-2 responsiveness in order to further narrow the application of IL-2 therapy to those who will benefit the most [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
tumor tissue, blood
| Estimated Enrollment: | 153 |
| Study Start Date: | February 2010 |
| Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
IL-2 subjects
Subjects receiving IL-2 for advanced melanoma
|
Other: Observation
Observation only
|
Detailed Description:
Original tumor slides will be collected to identify tumor markers that may predict responses to treatment. Blood samples will be obtained prior to treatment with IL-2.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects enrolled on DF/HCC Protocol 06-149
Criteria
Inclusion Criteria:
- Malignant melanoma that is metastatic or unresectable
- Eligible to receive high-dose IL-2
- Tissue block available with adequate tumor to perform RNA extraction and DASL analysis
Exclusion Criteria:
- Prior immunotherapy for unresectable or metastatic disease
- Untreated brain metastases, leptomeningeal disease, or seizure disorder
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288963
Contacts
| Contact: David McDermott, MD | 617-632-9250 | dmcdermo@bidmc.harvard.edu |
Locations
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: David McDermott, MD | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
| Principal Investigator: | David McDermott, MD | Beth Israel Deaconess Medical Center |
More Information
No publications provided
| Responsible Party: | David McDermott, MD, Beth Isreal Deaconess Medical Center |
| ClinicalTrials.gov Identifier: | NCT01288963 History of Changes |
| Other Study ID Numbers: | 09-333 |
| Study First Received: | February 1, 2011 |
| Last Updated: | April 7, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dana-Farber Cancer Institute:
|
melanoma IL-2 Aldesleukin |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Aldesleukin Interleukin-2 Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 21, 2013